Table 5.
Peak0–3 FEV1 response at study Day 1 and Day 43 and trough FEV1 responses after 6 weeks of treatment, showing the differences between treatments (full analysis set)
| Treatment comparison
|
||||
|---|---|---|---|---|
| Tiotropium + olodaterol 5/5 µg versus
|
Tiotropium + olodaterol 2.5/5 µg versus
|
|||
| Salmeterol + fluticasone propionate 50/500 µg | Salmeterol + fluticasone propionate 50/250 µg | Salmeterol + fluticasone propionate 50/500 µg | Salmeterol + fluticasone propionate 50/250 µg | |
| Peak0–3 FEV1, mL, Day 1 | ||||
| Adjusted mean (SE) | 80 (9) | 95 (9) | 61 (9) | 76 (9) |
| 95% CI | 62, 97 | 77, 112 | 44, 79 | 59, 94 |
| P-value | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| Peak0–3 FEV1, mL, Day 43 | ||||
| Adjusted mean (SE) | 147 (12) | 142 (12) | 116 (12) | 111 (12) |
| 95% CI | 123, 171 | 118, 166 | 92, 140 | 87, 135 |
| P-value | <0.0001 | <0.0001 | <0.0001 | <0.0001 |
| Trough FEV1, mL | ||||
| Adjusted mean (SE) | 58 (12) | 47 (12) | 54 (12) | 42 (12) |
| 95% CI | 34, 82 | 22, 71 | 29, 78 | 18, 67 |
| P-value | <0.0001 | 0.0002 | <0.0001 | 0.0007 |
Notes: The adjusted mean (SE) was obtained from fitting a mixed-effects repeated-measures model including the following: fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation; and Kenward–Roger approximation of denominator degrees of freedom.
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; peak0–3 FEV1, peak forced expiratory volume in 1 second from 0 hour to 3 hours; SE, standard error.